Senior Regulatory Affairs Specialist

About the role

The Senior Regulatory Affairs Specialist advises regulatory strategy for the company’s devices and ensures compliance to Regulatory requirements for the regions assigned (domestic/international).

They provide expertise in translating complex regulatory requirements into practical, workable plans, as well as interacts with regulatory agencies and with senior leadership to influence company decisions.

Responsibilities

• Assess and advise regulatory strategies to optimize business expectations related to domestic and international commercial product availability and regulations
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions
• Determine requirements and options for regulatory submissions, approval pathways, and compliance activities
• Develop global regulatory strategies and update based on changes in the regulatory landscape
• Ensure regulatory strategy outputs are properly communicated to development teams and leadership
• Lead the preparation of all necessary regulatory submissions (as assigned), in compliance with applicable regulatory requirements
• Communicate and interact with regulatory authorities before and during the development and review of a regulatory submissions
• Maintain US FDA establishment registrations and device listing per applicable regulatory requirements (as assigned)
• Maintain GS1 account and US FDA GUIDID entries per applicable regulatory requirements (as assigned)
• Review and approve engineering change orders for product modifications (as assigned)
• Review and assess impact of new regulations/guidance documents applicable to the company
• Train stakeholders on current and new regulatory requirements to ensure company-wide compliance
• Act as RA lead in external audits (FDA, MDSAP, EU MDR, UKCA, etc) to meet applicable regulatory requirements and maintain QMS certifications
• Support in recruiting, hiring, and training regulatory team members

Requirements

• History of successful regulatory clearances/approvals in global markets
• Thorough working knowledge of Quality System standards and regulations including but not limited to 21 CFR 820, ISO 13485, MDSAP, EU MDD/MDR, UKCA
• Thorough working knowledge of risk management and other standards including but not limited to ISO 14971, IEC 60601, and IEC 62304
• Extensive knowledge of regulatory strategy and approval approaches
• Strong knowledge of medical device labeling requirements
• Effective written and oral communication skills including the ability to interact with all levels of the company
• Proficient ability to read, analyze and interpret technical documents, professional journals, technical procedures, and regulations
• Ability to navigate effectively through the regulatory process as part of a team ensuring project and company success
• Detail-oriented, hands-on, proactive problem solver
• Ability to work with minimal supervision

Qualifications

• Bachelor’s degree in a scientific or regulatory discipline, plus 8 years' experience in the medical device industry; or equivalent work experience
• Minimum 5 years' experience in Regulatory Affairs role
• Experience interpreting FDA and international guidelines and regulations
• History of successful US FDA 510(k) clearances for Class II devices and interactions with regulators
• Experience with EU MDR, Health Canada, and Australia TGA regulatory submissions
• Experience with international registrations
• Proven track record of navigating swiftly and efficiently through the regulatory process as part of a team ensuring project and company success
• Extensive experience interpreting FDA and international regulatory guidelines, understating regulatory strategy and approval approaches, working directly and interacting with regulatory agencies
• Experience hosting audits

Preferred Qualifications

• Experience in Research & Development (R&D)
• Familiarity with AI-based software, medical imaging, active devices